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HLTINF002 Process Reusable Medical Devices And Equipment Unit

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  • Course Code: HLTINF002
  • University: Victoria University
  • Country: Australia


A case study is designed for you to demonstrate your skills in reading, accurately interpreting and providing workable responses and strategies.
Check that your responses provide:
1. Identification and clarification of the key issues.  Discuss and provide some suggestions as to what has caused these
2. Key facts and information that is relevant and demonstrates your ability to provide solutions
3. Templates and resources that could assist managers in the future when managing their teams
4.  Recommendations, both short term and long term, to improve the current situation 
Also ensure the appropriate use of headings and formats so as to reflect a professional presentation. 


Identification and clarification of the key issues.  Discuss and provide some suggestions as to what has caused these

If any instrument or piece of equipment is to be reused it requires reprocessing such as disinfection, sterilization, and or cleaning. The level of reprocessing the instruments that are reusable depends on the specific situation. There is an approach developed by Spaulding 30 years ago for patient care items and equipment. This approach is taken for sterilization and disinfection is still retained and refines it successfully. It is used by all professionals of infection control and also others whenever disinfection or sterilization method is planned (Rutala and Weber 2008).  On the basis of items and the instruments for patient care, the system is divided into critical, semi critical, and non-critical. This categorization is as per the level of risk of infection involved while using the items.

Critical: These items if contaminated with any microbes will deliberate a high risk of infection. Therefore, these are to be sterile whenever they are in use. For instance, objects which enter the vascular system or sterile tissue are included since any microbial contamination might transmit the disease.

Semi-critical: Items that come in contact with mucous membranes or non-intact skin is included under this. It should be of single use or it has to be sterile after every use. If that is not possible, then the level of disinfection should be at a high level.

Noncritical: Items that are not in contact with the mucous membrane but that come in contact with intact skin, is included under this. For most of the noncritical items, proper cleaning is enough after every individual use. However, either medium or low-level disinfection will be appropriate in certain situations.

Key facts and information that is relevant and demonstrates your ability to provide solutions

In the settings of dental healthcare, cleaning, sterilizing, and disinfecting of all instruments has to be taken place. It should occur in a selected central processing area so that it is made sure of safety and quality is controlled easily. The processing area of the instrument has to be divided physically into the following sections:

  1. Receiving it, then cleaning, and later decontamination
  2. Should go for preparation and then packaging
  • Sterilization and
  1. Storage

This categorization is designed in such a way so that all the items contaminated will go to that specific area for cleaning. By this contamination of the other clean areas are prevented where other processes like packaging, sterilization, and storage are done. In the cleaning area, contaminated instruments and devices that are to be reused are received, organized and cleaned will be kept.

For inspection, assembling, and then packaging of the instruments are taken place in the packaging area which is the final process of preparation. Steam sterilizers are to be loaded with utmost care. The items are to be packed properly and place it in the sterilizer. It works under the principle of steam under pressure. Then unload of materials is to be done after the pressure of the instrument comes down to normal temperature.

The sterilizers and the related supplies are maintained at the sterilization and the storage areas along with the incubators for analysing the spore tests. This area will also contain bounded storage space for storing the sterile and disposable items if physical separation of these areas is not possible than it has to be labelled properly. By this, each area will be maintained sterile from contaminated areas.

The personnel whoever is processing the instruments is to be trained properly in their work practices. This will prevent contamination of the cleaned and sterile areas. Sterilization records should be maintained for verifying that processing system is appropriate in that place. It should be in accordance with the state and federal legislation.


Templates and resources that could assist managers in the future when managing their teams

An integral part of sterilization is the maintenance and monitoring of the sterilizer regularly so that the equipment is maintained properly. Sterilizers are the equipment’s which are subjected to breakdowns and faults. Most of these machines are delicate, so they can only be maintained by cautious monitoring. The essential prerequisites required for the operation of the sterilizer are maintenance and monitoring. The general maintenance procedure is to be followed by the technician who is operating the sterilizing equipment.  

The procedure has to be carried out daily and or weekly so that it is well-maintained. Though this general maintenance might sound simple it is an essential part. This would be the routine checking and proper cleaning is to be carried out.

For determining the rate of air leaking into the chamber the leak rate test has to be performed. This is to be done for pre-vacuum sterilizers and is performed weekly. For checking the efficiency of the sterilization process the monitoring cycles are designed. The prescriptive standard is AS/NZ standard 4187 for regular monitoring. It has to be performed and recorded for all the sterilizers that are used within the SSD.

The testing method that is used and the importance of ensuring quality assurance of sterilisation equipment is calibration. This testing is carried out only on orders given by the sterility assurance committee of Australian Standards. This is performed every quarterly, half yearly, and annually. Based on the calibration history this testing is done, which will be forming an integral part of quality assurance. This calibration is documented.

Recommendations, both short term and long term, to improve the current situation  

  • It is always recommended strongly that whenever it is possible reprocessing has to be performed. Also, it has to be taken place in the centralized area only to prevent contamination. This area should comply the physical and the human resource requirements for the reprocessing method.
  • The chemical disinfectant that is used as the disinfectant for the medical devices and or equipment’ should follow the manufacturer’s instructions. Its instructions should be compatible with both manufacturer and cleaning products that are used for reprocessing.
  • On regarding the one time use of the medical equipment’s the health care settings should have the written policies
  • The medical devices or equipment’s of critical and semi-critical if at all labelled as one time use; then it should not be reprocessed. Also, it should not be reused till the time reprocessing is not done by a licensed reprocessor.
  • It is advisable that the workplace manager is required to take appropriate measures. These measures should be taken with respect to workplace policy and procedures for fixing the problems.


Gold, Kathryn M., and Victoria M. Hitchins. "Cleaning assessment of disinfectant cleaning wipes on an external surface of a medical device contaminated with artificial blood or Streptococcus pneumoniae." American journal of infection control 41, no. 10 (2013): 901-907.

Houser, Kevin L., Foster B. Stulen, William D. Dannaher, Bret W. Smith, David N. Plescia, Michael J. Stokes, Sora Rhee et al. "Medical device with feature for sterile acceptance of non-sterile reusable component." U.S. Patent 9,072,523, issued July 7, 2015.

Krucoff, Mitchell W., Art Sedrakyan, and Sharon-Lise T. Normand. "Bridging unmet medical device ecosystem needs with strategically coordinated registries networks." Jama 314, no. 16 (2015): 1691-1692.

Parker, Brent. "Reusable pulse oximeter probe and disposable bandage apparatii." U.S. Patent 8,706,179, issued April 22, 2014.

Scott, David, Hayley Kane, and Annette Rankin. "‘Time to clean’: A systematic review and observational study on the time required to clean items of reusable communal patient care equipment." Journal of Infection Prevention (2017): 1757177417714046.

Scully, Christopher G., Shawn Forrest, Loriano Galeotti, Suzanne B. Schwartz, and David G. Strauss. "Advancing regulatory science to bring novel medical devices for use in emergency care to market: the role of the Food and Drug Administration." Annals of emergency medicine 65, no. 4 (2015): 400-403.

Siebrecht, Wayne A., David J. Wesley, David B. Mogill, and Daniel S. Goldberger. "Handpiece for ultrasonic medical devices including seal for mechanical isolation of ultrasonic driver assembly." U.S. Patent 8,795,183, issued August 5, 2014.

Smith, Bret W., David N. Plescia, Michael J. Stokes, Sora Rhee, Timothy G. Dietz, Kevin D. Felder, Jeffrey L. Aldridge, and Emmanuel V. Tanghal. "Medical device packaging with window for insertion of reusable component." U.S. Patent 9,089,338, issued July 28, 2015.


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